Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis

Pain Clinical Trial

Official title:

Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03949400
• Other study ID #: FOU-UU-2018-007
• Status: Recruiting
• Start date: April 24, 2018
• Est. completion date: May 20, 2029

Study information

• Verified date: February 2019
• Source: University College of Northern Denmark
• Contact: Palle S Jensen, Adjunct
• Phone: +4581719719
• Email: plj[@]ucn.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary aim of the study is to investigate the effects of supervised exercise therapy and education on the immediate response to using a soft knee brace in patients with knee osteoarthritis (OA).

Description:

Study type: observational Estimated enrollment: 40 participants Observational model: cohort Time perspective: prospective

Inclusion Criteria:

Assigned for exercise and education due to knee osteoarthrosis Age 18 years or older at the time of recruitment Able to read and understand Danish

Exclusion Criteria:

Not mentally able to reply to the questionnaire

Patients are tested with and without the brace before starting the exercise therapy and education program and re-tested with and without the brace after completing the treatment program (6 weeks) and again at 12 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 20, 2029
• Est. primary completion date: April 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Assigned for exercise and education due to knee osteoarthrosis Age 18 years or older at the time of recruitment Able to read and understand Danish

Exclusion Criteria:

Not mentally able to reply to the questionnaire

Related Conditions & MeSH terms

• Adults
• Knee Brace
• Osteoarthritis
• Osteoarthritis, Knee
• Outcome Assessment (Health Care)
• Pain
• Patient Reported Outcome Measures
• Recovery of Function
• Rehabilitation
• Treatment Outcome

Intervention

Other:
• Exercise therapy and education.
Exercise therapy and education, physiotherapy rehab at Aalborg Municipality

Locations

Country	Name	City	State
Denmark	Aalborg Municipality, training unit west	Aalborg	Nothern

Sponsors (1)

Lead Sponsor	Collaborator
University College of Northern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knee injury and Osteoarthritis Outcome Score (KOOS) (continous)	An instrument to assess the patient's opinion about their knee and associated problems. KOOS has been evaluated and compared to other instruments in several studies. Measured at baseline, after the treatment program and at 12weeks.	6+12 weeks follow-up
Other	Pain manikin	Self-reported pain assessment by the patients.	6+12 weeks follow up
Other	Likert scale	Self-reported by the patients	6+12 weeks follow-up
Other	Analgetic pain medication intake	Self-reported by the patients.	6+12 weeks follow-up
Primary	Pain - Numerical rating scale (NRS)	NRS is the most common pain scale for quantification pain. The respondent selects a whole number on a scale from 0-10, that best reflects the intensity of his/her pain. 0 being no pain, 10 being the worst pain imaginable.	6+12 weeks follow-up
Secondary	Y-balance test (YBT)	The YBT test is a test commonly used in clinical practice to investigate functional balance. The YBT is based on the Star Excursion Balance Test and it has been thoroughly researched. Measured with and without the soft knee brace at baseline, after the treatment program and at 12weeks.	6+12 weeks follow-up
Secondary	Self-perceived knee stability question	Self-reported by the patients.	6+12 weeks follow-up
Secondary	40-meter walk test	A test of walking speed over shirt distances and changing direction during walking	6+12 weeks follow-up